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O-223 The Vici-trial: An International Multicenter Randomised Clinical Trial Comparing Hfo And Cmv As Initial Ventilation Strategy In Congenital Diaphragmatic Hernia
  1. K Snoek1,
  2. I Capolupo2,
  3. T Schaible3,
  4. A van Heijst4,
  5. A Greenough5,
  6. M Gorett Silva6,
  7. J Saldanha7,
  8. A Debeer8,
  9. C Pinto9,
  10. D Tibboel1,
  11. I Reiss10
  1. 1Intensive Care and Department of Pediatric Surgery, Erasmus MC- Sophia Children’s Hospital, Rotterdam, Netherlands
  2. 2Department of Medical and Surgical Neonatology, Bambino Gesu Children’s Hospital, Rome, Italy
  3. 3Department of Pediatrics, Universitätsmedizin Mannheim, Mannheim, Germany
  4. 4Department of Pediatrics Division of Neonatology, Radboud University Medical Centre, Nijmegen, Netherlands
  5. 5Division of Asthma Allergy and Lung Biology, King’s College London, London, UK
  6. 6Department of Pediatrics Division of Neonatology, Hospital San Joao, Porto, Portugal
  7. 7Department of Pediatrics Division of Neonatology, Hospital de Santa Maria, Lisboa, Portugal
  8. 8Neonatal Intensive Care Unit, University Hospital Leuven, Leuven, Belgium
  9. 9Department of Paediatric Intensive Care Unit, Hospital de Pediatrico, Coimbra, Portugal
  10. 10Department of Neonatology, Erasmus MC- Sophia Children’s Hospital, Rotterdam, Netherlands


Background Congenital diaphragmatic hernia (CDH) is a life-threatening anomaly with significant mortality and morbidity. The lungs have a high susceptibility for oxygen and ventilation damage resulting in a high incidence of chronic lung disease (CLD).

Aim To establish the optimal initial ventilation strategy in CDH.

Methods In a prospective, randomised international multicenter trial initiated by the CDH Euroconsortium (VICI-trial, NTR 1310), prenatally diagnosed CDH neonates born between November 2008 and December 2013, were randomised for either conventional mechanical ventilation (CMV) or high-frequency oscillation ventilation (HFO) as initial ventilation mode. Primary outcome measure was death or CLD (Jobe and Bancalari, 2001) at day 28 analysed by multiple logistic regression analysis corrected for centre, lung-to-head ratio, liver position and side of defect. Secondary outcome was corrected for centre.

Results Of the 171 included patients, 91 (53.2%) initially received CMV (median gestational age 38.1 weeks) and 80 (46.8%) HFO (median gestational age 38.0 weeks). In total, 21 (23.1%) patients ventilated by CMV died and 25 (31.3%) in HFO. Of the survivors, 21 (23.1%) had CLD in CMV and 18 (22.5%) in HFO. Primary outcome measure showed that in CMV 41 (45.1%) died or had CLD at day 28 and in HFO 43 (53.8%), OR 0.6, 95% CI [0.12–2.54]. Results of secondary outcome are shown in Table 1.

Conclusions Although the primary outcome was statistically not significant, CDH patients initially ventilated by CMV were ventilated less days, received inotropics less days, and received less often nitric oxide, sildenafil and ECMO compared to HFO.

Abstract O-223 Table 1

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